Acebutolol Hydrochloride

Product NDC
51407-667
11-digit product format
514070667
Labeler code
51407
Product ID
51407-667_462fa6dd-0afc-9a7f-e063-6294a90a5055
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acebutolol Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA074007
Marketing category
ANDA
Marketing start
1995-10-18
Substance
ACEBUTOLOL HYDROCHLORIDE
Active strength
400 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074007-001ACEBUTOLOL HYDROCHLORIDEACEBUTOLOL HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB1995-10-18
A074007-002ACEBUTOLOL HYDROCHLORIDEACEBUTOLOL HYDROCHLORIDEEQ 400MG BASECAPSULE / ORALAB1995-10-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A074007-001AB
A074007-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074007-001ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB1995-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07A074007-002ACEBUTOLOL HYDROCHLORIDEEQ 400MG BASECAPSULE / ORALAB1995-10-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074007-001ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB1995-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074007-002ACEBUTOLOL HYDROCHLORIDEEQ 400MG BASECAPSULE / ORALAB1995-10-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074007-001ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB1995-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074007-002ACEBUTOLOL HYDROCHLORIDEEQ 400MG BASECAPSULE / ORALAB1995-10-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A074007-001ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB1995-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074007-002ACEBUTOLOL HYDROCHLORIDEEQ 400MG BASECAPSULE / ORALAB1995-10-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074007-001ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB1995-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074007-002ACEBUTOLOL HYDROCHLORIDEEQ 400MG BASECAPSULE / ORALAB1995-10-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074007-001ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB1995-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074007-002ACEBUTOLOL HYDROCHLORIDEEQ 400MG BASECAPSULE / ORALAB1995-10-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074007-001ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB1995-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074007-002ACEBUTOLOL HYDROCHLORIDEEQ 400MG BASECAPSULE / ORALAB1995-10-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074007-001ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB1995-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074007-002ACEBUTOLOL HYDROCHLORIDEEQ 400MG BASECAPSULE / ORALAB1995-10-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074007-001ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB1995-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074007-002ACEBUTOLOL HYDROCHLORIDEEQ 400MG BASECAPSULE / ORALAB1995-10-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074007-001ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB1995-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074007-002ACEBUTOLOL HYDROCHLORIDEEQ 400MG BASECAPSULE / ORALAB1995-10-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074007-001ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB1995-10-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A074007-002ACEBUTOLOL HYDROCHLORIDEEQ 400MG BASECAPSULE / ORALAB1995-10-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074007-001ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB1995-10-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074007-002ACEBUTOLOL HYDROCHLORIDEEQ 400MG BASECAPSULE / ORALAB1995-10-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074007-001ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB1995-10-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074007-002ACEBUTOLOL HYDROCHLORIDEEQ 400MG BASECAPSULE / ORALAB1995-10-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074007-001ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB1995-10-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074007-002ACEBUTOLOL HYDROCHLORIDEEQ 400MG BASECAPSULE / ORALAB1995-10-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074007-001ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB1995-10-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074007-002ACEBUTOLOL HYDROCHLORIDEEQ 400MG BASECAPSULE / ORALAB1995-10-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074007-001ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASECAPSULE / ORAL1995-10-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074007-002ACEBUTOLOL HYDROCHLORIDEEQ 400MG BASECAPSULE / ORAL1995-10-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074007-001ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASECAPSULE / ORAL1995-10-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074007-002ACEBUTOLOL HYDROCHLORIDEEQ 400MG BASECAPSULE / ORAL1995-10-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074007-001ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASECAPSULE / ORAL1995-10-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074007-002ACEBUTOLOL HYDROCHLORIDEEQ 400MG BASECAPSULE / ORAL1995-10-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074007-001ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASECAPSULE / ORAL1995-10-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074007-002ACEBUTOLOL HYDROCHLORIDEEQ 400MG BASECAPSULE / ORAL1995-10-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074007-001ACEBUTOLOL HYDROCHLORIDEEQ 200MG BASECAPSULE / ORAL1995-10-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074007-002ACEBUTOLOL HYDROCHLORIDEEQ 400MG BASECAPSULE / ORAL1995-10-18bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074007-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074007-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074007-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074007-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074007-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074007-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074007-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074007-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074007-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074007-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074007-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074007-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074007-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074007-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074007-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074007-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074007-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074007-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074007-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074007-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074007-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074007-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074007-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074007-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074007-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074007-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074007-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074007-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074007-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074007-002AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074007-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074007-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074007-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A074007-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074007-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A074007-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074007-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074007-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074007-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074007-002AB19b2671bbb829…

Additional Listing Data#

Finished product
Yes
Brand name base
Acebutolol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACEBUTOLOL HYDROCHLORIDE400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B025Y34C54Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998685Internal RxNorm lookup
998689Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f037a079-fde6-3588-e053-2995a90a6621Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b2b9ebc1-3e2b-b877-2cfb-b7c92cf3c5faProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-667-01Acebutolol Hydrochloride100 in 1 BOTTLECAPSULE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-667-01EA - Each51407-667a8adc466-2ca2-4a87-9f23-c7478c77df6f12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-667ACEBUTOLOL HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]3Current NDC, Legacy NDC, 1 package rows20230325_f037a079-fde6-3588-e053-2995a90a6621.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acebutolol HydrochlorideACEBUTOLOL HYDROCHLORIDEGolden State Medical Supply, Inc.f037a079-fde6-3588-e053-2995a90a66212025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074007
application number: ANDA074007
ndc (product): 51407-667
Acebutolol HydrochlorideACEBUTOLOL HYDROCHLORIDEANI Pharmaceuticals, Inc.48bded12-09c7-47f2-b162-ec970a77f2d82025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074007
application number: ANDA074007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998689acebutolol HCl 200 MG Oral CapsulePSNf037a079-fde6-3588-e053-2995a90a66214
998685acebutolol HCl 400 MG Oral CapsulePSNf037a079-fde6-3588-e053-2995a90a66214
998689acebutolol 200 MG Oral CapsuleSCDf037a079-fde6-3588-e053-2995a90a66214
998685acebutolol 400 MG Oral CapsuleSCDf037a079-fde6-3588-e053-2995a90a66214
998689acebutolol (as acebutolol HCl) 200 MG Oral CapsuleSYf037a079-fde6-3588-e053-2995a90a66214
998685acebutolol (as acebutolol HCl) 400 MG Oral CapsuleSYf037a079-fde6-3588-e053-2995a90a66214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-667-0151407066701100 CAPSULE in 1 BOTTLE (51407-667-01) 100 capsule2022-08-010000-00-00NoNoCurrent